BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTSTART MRX EMS DEFIBRILLATOR

    MDR report key: 1933786 · Received December 14, 2010

    Report

    Report Number
    1218950-2010-02586
    Event Type
    Death
    Date Received
    December 14, 2010
    Date of Event
    November 20, 2010
    Report Date
    November 22, 2010
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THIS CUSTOMER REPORTED THAT THE DEFIBRILLATOR PRINTED AND SAVED ONLY 12 SECONDS OF THE ELECTRONIC EVENT FILE FROM A PT EVENT. THE INVOLVED PT DIED, BUT THE CUSTOMER HAS NOT STATED THAT THE DEVICE WAS A FACTOR IN THE PT OUTCOME. A FOLLOW-UP REPORT WILL BE SUBMITTED AFTER PHILIPS OBTAINS MORE INFO ABOUT THIS EVENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DEFIBRILLATOR PRINTED AND SAVED ONLY 12 SECONDS OF THE ELECTRONIC EVENT FILE FROM A PT EVENT. THE INVOLVED PT DIED, BUT THE CUSTOMER HAS NOT STATED THAT THE DEVICE WAS A FACTOR IN THE PT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTSTART MRX EMS DEFIBRILLATOR MKJ PHILIPS HEALTHCARE M3536A

    Patients

    Seq Age Sex Outcome Treatment
    1